MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Model Number AB2000

Device Problems Infusion or Flow Problem (2964); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during the aquablation procedure the aquabeam handpiece was unable to aspirate despite multiple troubleshooting steps taken.As a result the handpiece was replaced with a new handpiece unit and the aquablation procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

Manufacturer Narrative

Investigation is currently in-process.No root cause has yet been determined.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.No issues were found with the console.How the errors occurred remains undeterminable as no problems were detected during testing.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam was not returned for investigation.The investigation is based on the information received plus a review of the device history record and labeling.A review of the device history record (dhr) ab2000-b / serial number (b)(6).And aquabeam handpiece / lot number (b)(6).Was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: 4.3 warnings: procedure · throughout the procedure, monitor the patient for unanticipated movement and immediately release the foot pedal to stop the procedure if movement is observed.Patient movement during the procedure may result in serious injury.· ensure the motorpack magnetic latch is pointing towards the black indicator.Clear any excess drape and seams off the magnet plate on the motorpack.Patient/user injury could occur with unanticipated movement of the motorpack.· active fluid evacuation/aspiration from bladder is operational during the aquablation procedure but be attentive for any occluding tissue in the aspiration tubing during the procedure.The root cause of the reported event was unable to be established as the device was not returned for investigation.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 15831809
• MDR Text Key: 304010918
• Report Number: 3012977056-2022-00159
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200930C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male